A Study That Will Compare the Effect of Two Drugs on Participants With Low Bone Mass and a Recent Hip Fracture

What Was Tested

The trial (phase 4) is built around Teriparatide for osteoporosis and bone density.

It had two arms (groups): Teriparatide (experimental) and Risedronate (active comparator).

The registry classes the interventions as dietary supplement and drug.

Who Took Part

224 actual participants took part.

It was open to people of any sex aged from 50 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Men and postmenopausal women aged ≥50 who have sustained a unilateral, fracture of the trochanteric region.

The full record lists 2 inclusion and 3 exclusion criteria; among the exclusions: history of unresolved skeletal diseases that affect bone metabolism; polytrauma participants and participants with fractures at more than one site.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

The osteoporosis and bone density participants were allocated by chance, so the Teriparatide group and the comparison group should start out alike.

The Teriparatide group and the comparison group ran side by side rather than switching.

As a double-blind Teriparatide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2009-04 with completion listed for 2015-08.

It ran at 28 sites in United States (6), Spain (5), France (4), Czechia (2), Denmark (2) and Italy (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in Lumbar Spine Areal Bone Mineral Density (BMD) (time frame: Baseline, Week 78).

It also tracked 6 secondary outcomes, for example Change in Lumbar Spine Areal Bone Mineral Density, Change in Areal Bone Mineral Density Measured at the Femoral Neck and Total Hip of the Non-Fractured Limb, Change From Baseline in Physical Component Summary of the Short Form-36 (SF-36) Questionnaire, Percentage of Participants Reporting Hip Pain in Modification of the Charnley's Pain Scale, Visual Analog Scale (VAS) and Timed "Up and Go" Test.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Teriparatide in 224 people with osteoporosis and bone density.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Teriparatide compound page, Osteoporosis and bone density research.